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| ID | Type | Description | Link |
|---|---|---|---|
| CTOR-501 |
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Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| senofilcon A toric | Experimental | senofilcon A, daily wear, toric contact lens worn for two weeks |
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| balafilcon A toric | Active Comparator | balafilcon A, daily wear, toric contact lens worn for two weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| senofilcon A toric | Device | silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement) |
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| Measure | Description | Time Frame |
|---|---|---|
| Lens Orientation | Proportion of eyes with lens orientation within 5 degrees of optimal | 1 minute after insertion |
| Lens Stability | Lens stability is measured as the amount of rotation induced from blink after the lens has settled. | 10-15 minutes after insertion |
| Subjective Comfort | Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5. | 2 weeks of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Fit Lens | Time required for the optometrist to fit the lens. | after lens insertion |
| Subjective Lens Vision | A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data. |
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Inclusion Criteria:
Be between 18 and 45 years of age.
Sign Written Informed Consent (See separate document).
Be an existing successful daily wear toric soft contact lens.
Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
Does not require presbyopic correction (can read J1 @ normal reading distance).
Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
Have refractive astigmatism between 0.75D and 2.50D in both eyes.
Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Graeme YOung, MPhil PhD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camp Eye Care Clinic | North Little Rock | Arkansas | 72116 | United States | ||
| James R. Dugue, O.D. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Senofilcon A Toric | senofilcon A toric contact lens. Analysis includes participants that completed the study. |
| FG001 | Balafilcon A Toric | balafilcon A toric contact lens. Analysis includes participants that completed the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| balafilcon A toric | Device | silicone hydrogel toric lens, worn daily for 2 wks (2wks replacement) |
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| measured at 1 and 2 weeks |
| Overall Corneal Staining | National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. | After 2 weeks use |
| Mission Viejo |
| California |
| 92691 |
| United States |
| Executive Park Eye Care | Colorado Springs | Colorado | 80909 | United States |
| Dr. Ted Brink and Associates | Jacksonville | Florida | 32256 | United States |
| Grene Vision Group | Neodesha | Kansas | 66757 | United States |
| Advanced Eyecare, PC | Raytown | Missouri | 64133 | United States |
| Dr. James Brobst | Florence | New Jersey | 08518 | United States |
| Fine Eye Care Associates | Rochester | New York | 14623 | United States |
| Warren Ophthalmology Associates | Warren | Ohio | 44484 | United States |
| Selden Eyecare LLC | Kittanning | Pennsylvania | 16201 | United States |
| Nittany Eye Associates | State College | Pennsylvania | 16801 | United States |
| Dr. David W. Ferris and Associates | Warwick | Rhode Island | 02886 | United States |
| Dr. Larry Menning | Chamberlain | South Dakota | 57325-0490 | United States |
| Wishnow-Sugar Vision Group | Katy | Texas | 77450 | United States |
| Dr. William Bogus | Salt Lake City | Utah | 84106 | United States |
| Midlothian Optometric Center | Midlothian | Virginia | 23113 | United States |
| The Eye Specialists, Ltd. | Virginia Beach | Virginia | 23455 | United States |
| The Eye & Contact Lens Clinic | Bremerton | Washington | 98310 | United States |
| Matus Eyecare | Franklin | Wisconsin | 53132 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Senofilcon A Toric | senofilcon A toric contact lens. Analysis includes participants that completed the study. |
| BG001 | Balafilcon A Toric | balafilcon A toric contact lens. Analysis includes participants that completed the study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Gender of 2 subjects assigned to balafilcon A is unknown. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Lens Orientation | Proportion of eyes with lens orientation within 5 degrees of optimal | Analysis was performed on participants who completed the study per protocol. The data represents 274 eyes that wore senofilcon A lenses and 278 eyes that wore balafilcon A lenses. | Posted | Number | proportion of eyes | 1 minute after insertion | eyes | Participants |
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| Primary | Lens Stability | Lens stability is measured as the amount of rotation induced from blink after the lens has settled. | Analysis was performed on participants who completed the study per protocol. | Posted | Number | proportion of eyes | 10-15 minutes after insertion | eyes | Participants |
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| Secondary | Time to Fit Lens | Time required for the optometrist to fit the lens. | Analysis was performed on participants who completed the study per protocol. | Posted | Least Squares Mean | Standard Error | minutes | after lens insertion |
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| Secondary | Subjective Lens Vision | A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. >0 = satisfactory vision, < 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data. | Analysis was performed on participants who completed the study per protocol. | Posted | Least Squares Mean | Standard Error | units on a scale | measured at 1 and 2 weeks |
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| Secondary | Overall Corneal Staining | National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion. | Analysis was performed on participants who completed the study per protocol. | Posted | Least Squares Mean | Standard Error | units on a scale | After 2 weeks use |
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| Primary | Subjective Comfort | Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. >0 = comfortable, < 0 = uncomfortable. Combined measures from Week 1 and Week 5. | Analysis was performed on participants who completed the study per protocol. | Posted | Least Squares Mean | Standard Error | units on a scale | 2 weeks of lens wear |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Senofilcon A Toric | senofilcon A toric contact lens. Analysis includes participants that completed the study. | 0 | 133 | 0 | 133 | ||
| EG001 | Balafilcon A Toric | balafilcon A toric contact lens. Analysis includes participants that completed the study. | 0 | 133 | 0 | 133 |
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The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kurt Moody OD | Vistakon | 904-443-3088 |
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